Product Details for NDA 021475
METHYLIN (METHYLPHENIDATE HYDROCHLORIDE)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLIN
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021475
Product Number: 001
Approval Date: Apr 15, 2003
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
METHYLIN (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLIN
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021475
Product Number: 001
Approval Date: Apr 15, 2003
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLIN
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021475
Product Number: 002
Approval Date: Apr 15, 2003
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
METHYLIN (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLIN
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021475
Product Number: 002
Approval Date: Apr 15, 2003
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLIN
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021475
Product Number: 003
Approval Date: Apr 15, 2003
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: METHYLIN
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021475
Product Number: 003
Approval Date: Apr 15, 2003
Applicant Holder Full Name: SPECGX LLC
Marketing Status: Discontinued
Patent and Exclusivity Information